The Study to Describe Symptom Control and Impact on Daily Life in Gastroesophageal Reflux Disease (GERD) Patients

April 16, 2012 updated by: AstraZeneca

An Epidemiological, Observational Study to Describe Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease (GERD)

The purpose of this study is to evaluate symptoms control and impact on daily life from patients perspective using specific GERD Impact Scale(GIS) questionnaire. The another objective is to obtain local epidemiological data for Bosnia and Herzegovina regarding GERD treatment in primary care.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1233

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bosnia and Herzegovina
      • Banja Luka, Bosnia and Herzegovina
        • Research Site
      • Bijeljina, Bosnia and Herzegovina
        • Research Site
      • Derventa, Bosnia and Herzegovina
        • Research Site
      • Doboj, Bosnia and Herzegovina
        • Research Site
      • Gracanica, Bosnia and Herzegovina
        • Research Site
      • Gradacac, Bosnia and Herzegovina
        • Research Site
      • Gradiska, Bosnia and Herzegovina
        • Research Site
      • Hadzici, Bosnia and Herzegovina
        • Research Site
      • Jelah, Bosnia and Herzegovina
        • Research Site
      • Laktasi, Bosnia and Herzegovina
        • Research Site
      • Lukavac, Bosnia and Herzegovina
        • Research Site
      • Lukavica, Bosnia and Herzegovina
        • Research Site
      • Matuzici, Bosnia and Herzegovina
        • Research Site
      • Mostar, Bosnia and Herzegovina
        • Research Site
      • Pale, Bosnia and Herzegovina
        • Research Site
      • Prijedor, Bosnia and Herzegovina
        • Research Site
      • Sarajevo, Bosnia and Herzegovina
        • Research Site
      • Trn, Bosnia and Herzegovina
        • Research Site
      • Tuzla, Bosnia and Herzegovina
        • Research Site
      • Visoko, Bosnia and Herzegovina
        • Research Site
      • Vogosca, Bosnia and Herzegovina
        • Research Site
      • Zaluzani, Bosnia and Herzegovina
        • Research Site
      • Zivinice, Bosnia and Herzegovina
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients previously diagnosed with GERD (disease duration =3 years) or newly diagnosed patients that are currently not treted with proton pump inhibitors, for whom GP or specialist (in primary care unit) have previosly decided to initiate or change treatment for GERD.

Description

Inclusion Criteria:

  • Patients previously diagnosed with GERD (disease duration =3 years) or newly diagnosed patients that are currently not treated with proton pump inhibitor, for whom specialist or General Practionaire (GP) have previously decided to initiate or change treatment for GERD; Patients should be treated for GERD according to current practice

Exclusion Criteria:

  • Females of childbearing potential should not be pregnant or nursing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years
Time Frame: Maximum of 14 weeks, with 3 visits in total
Maximum of 14 weeks, with 3 visits in total
Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years
Time Frame: Visit 1 (enrolment)
Visit 1 (enrolment)
Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years
Time Frame: Visit 2 (4-6 weeks after Visit 1)
Visit 2 (4-6 weeks after Visit 1)
Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years
Time Frame: Visit 3 (8-14 weeks after Visit 1).
Visit 3 (8-14 weeks after Visit 1).

Secondary Outcome Measures

Outcome Measure
Time Frame
The evaluation of GERD Impact Scale (GIS questionnaire) as a useful tool for initial and long term management of GERD patients
Time Frame: Maximum of 14 weeks, with 3 visits in total: Visit 1 (enrolment), Visit 2 (4-6 weeks after Visit 1) and Visit 3 (8-14 weeks after Visit 1).
Maximum of 14 weeks, with 3 visits in total: Visit 1 (enrolment), Visit 2 (4-6 weeks after Visit 1) and Visit 3 (8-14 weeks after Visit 1).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Srdjan Gornjakovic, MD, PhD, Clinical Center University of Sarajevo; Department of Gastrenterology and HepatologySarajevo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

September 7, 2010

First Submitted That Met QC Criteria

September 10, 2010

First Posted (Estimate)

September 13, 2010

Study Record Updates

Last Update Posted (Estimate)

April 17, 2012

Last Update Submitted That Met QC Criteria

April 16, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-GBA-DUM-2010/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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